Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Key responsibilities:

• Provides on-site management and direction to laboratory staff and resources for project activities and needs, oversee daily operations to monitor quality and project timelines, and assist in preparation and implementation of company policies, quality systems and training programs.

• Coordinate with client’s project lead(s) to define analytical work packages (i.e., method development/validation, reference standard characterization, batch release and stability testing for biologic drug substances/drug products) and schedule activities within your analytical team.

• Review and verify experimental data/electronic lab notebook experiments for formulation/process development samples and clinical trial supplies (e.g. cGMP compliant stability and batch release testing) for drug substances and drug products.

• Training of junior staff on new analytical techniques and revised analytical procedures.

• Author and/or review method protocols/validation reports, stability protocols, technical memos and other lab reports.

• Mentor junior staff in experimental design for method development and validation activities.

• Mentor junior staff in troubleshooting of equipment and experimental problems.

• Encourage ideas for continuous improvement activities and initiatives within work group.

• Understand and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.

Education and Experience:

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar

• AGL: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6+years’)

• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4+ years’)

• OR PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 2+ years’)

• GL: · Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’)

• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6+ years’)

• OR PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4+ years’)

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Validated leadership skills and proven ability to perform supervisory tasks

• Ability to manage daily operations for a team of approximately 9 direct reports

• Experience in analytical methodology, such as chromatography, KF, UV and compendial methods and bioanalytical techniques preferred (WCX, HIC, SEC, CGE, particle imaging, ELISA and LC-MS).

• Experienced in laboratory systems (LIMS, CDS, ELN) preferred.

• Statistical knowledge and experience is preferred, e.g. capability analysis, gauge R&R and design of experiments (DOE) methodologies.

• Ability to cultivate a collaborative work environment within a team

• Ability to troubleshoot multiple systems/methodologies

• Ability to independently optimize analytical methods

• Understanding of basic financial terms and definitions as it applies to the business

• Understanding of proposal and project scope as it relates to pricing, resource management and the impact on business

Working Environment:

Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary and/or standing for typical working hours.

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with

proficiency.

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Compensation and Benefits

The salary range estimated for this position based in Illinois is $85,000.00–$100,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.